Coronary Artery Disease, Healthy Participants
Conditions
Keywords
Thrombosis, Coronary Artery Disease, Healthy Participants, Aspirin, Ticagrelor, Brilinta, BMS-986141
Brief summary
The purpose of this study is to assess the effectiveness, safety and tolerability of BMS-986141 added on to aspirin or ticagrelor or the combination on thrombus formation in both healthy participants and participants with stable coronary artery disease.
Interventions
DRUGTicagrelor
Specified dose on specified days
DRUGBMS-986141
Specified dose on specified days
DRUGAspirin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: * Male or female between 18 to 75 years of age, inclusive, and body mass index (weight kg/m2) between 18 and 35 kg/m2 (inclusive), and body weight 50 kg and 120 kg (inclusive) * Judged to be generally in good health based on medical history, physical examination, ECGs, vital signs and laboratory tests * Signed an informed consent document indicating they understand the purpose of and procedures required for the experiment and are willing to participate in the experiment * Willing/able to adhere to the visit schedule * For treatment arms groups with stable CAD participants (not for healthy volunteers without CAD) one or more of: Prior angiographically proven CAD (\>50% stenosis of proximal coronary artery), prior coronary revascularization (PCI or CABG), prior myocardial infarction (MI)
Exclusion criteria
* Participants who meet any of the following criteria will be excluded from participating in the experiment: Allergies or intolerance of aspirin, ticagrelor and BMS-986141, requirement for dual antiplatelet therapy, requirement for anticoagulant therapy * Acute Coronary syndrome or coronary revascularization within 3 months * Coagulation disorders (including any abnormal bleeding or blood dyscrasias), anemia, renal or hepatic insufficiency or any others illness that the investigator considers should exclude the participants/patients of that could interfere with the interpretation to the results * Acute illness, including a common cold, within 7 days prior to visit or other significant acute or chronic medical illness * Major or traumatic surgery within 12 weeks of screening * History of, a reason to believe that, a blood donor subject has a history of drug or alcohol abuse within the past 5 years or has not abstained from alcohol for at least 24 hours prior to visit * Positive serum or urine pregnancy test * Not anatomically suitable for or unwilling to undergo venipunctures * Participation in a study of an investigational medicinal product within the last 4 weeks * Any condition that, in the opinion of the investigator, would compromise the wellbeing of the blood donor subject or the experiment or prevent the blood donor subject from meeting or performing experiment requirements Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Thrombus Area | Baseline, Day 1 hour 2, Day 2 hour 24 | The change from baseline in thrombus area post-treatment with BMS-986141 versus pretreatment. Baseline is defined as the last non-missing result (including repeated and unscheduled assessments) with a collection date-time less than the datetime of study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Clinical Lab Abnormalities | From baseline up to 24 hours post dose | The number of participants with abnormal clinical laboratory results. The criteria used for classifying laboratory test results as markedly abnormal is listed below. |
| Number of Participants Experiencing Abnormal Vital Signs | Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2 | The number of participants with abnormal vital sign values. The criteria used for classifying vital sign results as markedly abnormal is listed below. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication. For Treatment Arms 1, 2, and 3, a baseline chamber run was performed approximately 2 hours after background therapy (ticagrelor, aspirin, or ticagrelor + aspirin) and prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. For Treatment Arm 4, a baseline chamber run was performed prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. Participants received background therapy before the final chamber run, and the final chamber run was performed on Day 2, approximately 24 hours after BMS-986141 dosing. |
| Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing | The number of participants with abnormal electrocardiogram values. The criteria used for classifying electrocardiogram results as markedly abnormal is listed below. The 2-hour and 24-hour ECGs should are performed prior to the Badimon Chamber run. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication. |
| Number of Participants Experiencing Adverse Events (AEs) | From first dose up to 8 days post last dose | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. |
Countries
United Kingdom
Participant flow
Pre-assignment details
58 participants received study treatment
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2. | 16 |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2. | 15 |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2. | 16 |
| Arm 4: Heathy Participants Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1. | 11 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
| Overall Study | Failure to meet continuation criteria | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Total | Arm 4: Heathy Participants | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 |
|---|---|---|---|---|---|
| Age, Continuous | 65.6 Years STANDARD_DEVIATION 5.4 | 58.3 Years STANDARD_DEVIATION 15.4 | 31.0 Years STANDARD_DEVIATION 11.9 | 62.3 Years STANDARD_DEVIATION 6.1 | 66.3 Years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 58 Participants | 11 Participants | 16 Participants | 15 Participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 12 Participants | 48 Participants | 8 Participants | 16 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 | 0 / 16 | 0 / 11 |
| other Total, other adverse events | 6 / 16 | 0 / 15 | 4 / 16 | 1 / 11 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 | 0 / 16 | 0 / 11 |
Outcome results
Primary
Percent Change From Baseline in Thrombus Area
The change from baseline in thrombus area post-treatment with BMS-986141 versus pretreatment. Baseline is defined as the last non-missing result (including repeated and unscheduled assessments) with a collection date-time less than the datetime of study medication.
Time frame: Baseline, Day 1 hour 2, Day 2 hour 24
Population: Biomarker population-all treated participants who had any available biomarker data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | On-treatment Day 1, Hour 2, Low Shear | 10.0 Percent Change | Standard Deviation 260.3 |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | On-treatment Day 1, Hour 2, High Shear | -23.0 Percent Change | Standard Deviation 24.1 |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | Post-treatment Day 2, Hour 24, Low Shear | 20.7 Percent Change | Standard Deviation 134.6 |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | Post-treatment Day 2, Hour 24, High Shear | -4.8 Percent Change | Standard Deviation 30 |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | On-treatment Day 1, Hour 2, High Shear | -18.4 Percent Change | Standard Deviation 27.5 |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | Post-treatment Day 2, Hour 24, Low Shear | 579.6 Percent Change | Standard Deviation 2125.4 |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | Post-treatment Day 2, Hour 24, High Shear | -3.5 Percent Change | Standard Deviation 67.1 |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | On-treatment Day 1, Hour 2, Low Shear | 538.6 Percent Change | Standard Deviation 1803.3 |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | Post-treatment Day 2, Hour 24, Low Shear | 31.0 Percent Change | Standard Deviation 130 |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | On-treatment Day 1, Hour 2, High Shear | -24.2 Percent Change | Standard Deviation 17.2 |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | Post-treatment Day 2, Hour 24, High Shear | -10.6 Percent Change | Standard Deviation 24 |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Percent Change From Baseline in Thrombus Area | On-treatment Day 1, Hour 2, Low Shear | 104.2 Percent Change | Standard Deviation 383.5 |
| Arm 4: Heathy Participants | Percent Change From Baseline in Thrombus Area | Post-treatment Day 2, Hour 24, High Shear | -23.0 Percent Change | Standard Deviation 22.2 |
| Arm 4: Heathy Participants | Percent Change From Baseline in Thrombus Area | On-treatment Day 1, Hour 2, High Shear | -27.7 Percent Change | Standard Deviation 24.4 |
| Arm 4: Heathy Participants | Percent Change From Baseline in Thrombus Area | On-treatment Day 1, Hour 2, Low Shear | -14.9 Percent Change | Standard Deviation 50.2 |
| Arm 4: Heathy Participants | Percent Change From Baseline in Thrombus Area | Post-treatment Day 2, Hour 24, Low Shear | -2.5 Percent Change | Standard Deviation 41.6 |
Secondary
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
The number of participants with abnormal electrocardiogram values. The criteria used for classifying electrocardiogram results as markedly abnormal is listed below. The 2-hour and 24-hour ECGs should are performed prior to the Badimon Chamber run. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication.
Time frame: Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Baseline <120 | 5 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Baseline >=210 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <210 | 4 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=210 | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Baseline <210 | 5 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Baseline >=120 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 <120 | 5 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 >=120 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Baseline <500 | 5 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Baseline >=500 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <500 | 5 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=500 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Baseline <450 | 5 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Baseline >=450 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <450 | 5 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=450 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Baseline >=120 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Baseline <500 | 6 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=450 | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=500 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <450 | 5 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Baseline >=500 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <210 | 5 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <500 | 6 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Baseline <120 | 6 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 <120 | 6 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=210 | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Baseline >=210 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Baseline <450 | 6 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 >=120 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Baseline >=450 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Baseline <210 | 6 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Baseline >=120 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Baseline <120 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Baseline >=450 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 <120 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 >=120 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=450 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Baseline <500 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Baseline >=500 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <450 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <500 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=500 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Baseline <210 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Baseline >=210 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Baseline <450 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <210 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=210 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=450 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 >=120 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <210 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Baseline <210 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Baseline >=450 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 <120 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Baseline <450 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Baseline >=210 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Baseline <120 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Baseline >=500 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QRS DURATION, AGGREGATE (MSEC) Baseline >=120 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <500 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <450 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Baseline <500 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=210 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=500 | 0 Participants |
Secondary
Number of Participants Experiencing Abnormal Vital Signs
The number of participants with abnormal vital sign values. The criteria used for classifying vital sign results as markedly abnormal is listed below. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication. For Treatment Arms 1, 2, and 3, a baseline chamber run was performed approximately 2 hours after background therapy (ticagrelor, aspirin, or ticagrelor + aspirin) and prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. For Treatment Arm 4, a baseline chamber run was performed prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. Participants received background therapy before the final chamber run, and the final chamber run was performed on Day 2, approximately 24 hours after BMS-986141 dosing.
Time frame: Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Pre-Chamber Run | 4 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 Day 1 Pre-Chamber Run | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Post-Chamber Run | 5 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Day 1 | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Pre-Chamber Run | 2 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Post-Chamber Run | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Post-Chamber Run | 2 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Pre-Chamber Run | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 2 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Post-Chamber Run | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 2 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Pre-Chamber Run | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Pre-Chamber Run | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Day 1 HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Post-Chamber Run | 2 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Day 1 > 90 AND CHANGE FROM BASELINE > 10 | 2 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) 2 Hour Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) 2 Hour Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Pre-Chamber Run | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Day 1 | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Day 1 > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 Day 1 Pre-Chamber Run | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Pre-Chamber Run | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Pre-Chamber Run | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Pre-Chamber Run | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Day 1 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Post-Chamber Run | 3 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Pre-Chamber Run | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Post-Chamber Run | 2 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Pre-Chamber Run | 4 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Day 1 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Day 1 HR < 55 AND CHANGE FROM BASELINE < -15 | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Post-Chamber Run | 2 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Pre-Chamber Run | 3 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) 2 Hour Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Post-Chamber Run | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Post-Chamber Run | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) 2 Hour Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Pre-Chamber Run | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Day 1 > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Day 1 HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) 2 Hour Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) 2 Hour Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Day 1 | 3 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Pre-Chamber Run | 3 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Post-Chamber Run | 4 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Pre-Chamber Run | 4 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Post-Chamber Run | 2 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Pre-Chamber Run | 6 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Post-Chamber Run | 8 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 Day 1 Pre-Chamber Run | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Pre-Chamber Run | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Post-Chamber Run | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Post-Chamber Run | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Day 1 | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Abnormal Vital Signs | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Pre-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Day 1 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Pre-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 Day 1 Pre-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) 2 Hour Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) 2 Hour Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Day 1 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Pre-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Day 1 HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Post-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | HEART RATE (BEATS/MIN) Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Pre-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 1 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Day 1 > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Post-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Post-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Pre-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Pre-Chamber Run | 1 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Post-Chamber Run | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Post-Chamber Run | 1 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Abnormal Vital Signs | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Pre-Chamber Run | 0 Participants |
Secondary
Number of Participants Experiencing Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Time frame: From first dose up to 8 days post last dose
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Adverse Events (AEs) | 6 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Adverse Events (AEs) | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Adverse Events (AEs) | 4 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Adverse Events (AEs) | 1 Participants |
Secondary
Number of Participants Experiencing Clinical Lab Abnormalities
The number of participants with abnormal clinical laboratory results. The criteria used for classifying laboratory test results as markedly abnormal is listed below.
Time frame: From baseline up to 24 hours post dose
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | MAGNESIUM, SERUM (MEQ/L)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | BLOOD UREA NITROGEN (MG/DL)-Abnormal High | 3 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, URINE (N/A)-Abnormal High | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | PHOSPHORUS, INORGANIC (MG/DL)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | CALCIUM, TOTAL (MG/DL)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | POTASSIUM, SERUM (MEQ/L)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | ERYTHROCYTES (X10*6 C/UL)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | CHLORIDE, SERUM (MEQ/L)-Abnormal High | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | RBC, URINE (HPF)-Abnormal High | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | PROTEIN, URINE (N/A)-Abnormal High | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | HEMOGLOBIN (G/DL)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | LEUKOCYTES (X10*3 C/UL)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | HEMATOCRIT (%)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | CREATINE KINASE (U/L)-Abnormal High | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | ALBUMIN (G/DL)-Abnormal Low | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | LEUKOCYTES (X10*3 C/UL)-Abnormal High | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | WBC, URINE (HPF)-Abnormal High | 1 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | PROTEIN, TOTAL (G/DL) -Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal High | 2 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | NEUTROPHILS (ABSOLUTE) (X10*3 C/UL)-Abnormal Low | 0 Participants |
| Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | BLOOD, URINE (N/A)-Abnormal High | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | CREATINE KINASE (U/L)-Abnormal High | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | HEMOGLOBIN (G/DL)-Abnormal Low | 2 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | HEMATOCRIT (%)-Abnormal Low | 2 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | ERYTHROCYTES (X10*6 C/UL)-Abnormal Low | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | LEUKOCYTES (X10*3 C/UL)-Abnormal Low | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | LEUKOCYTES (X10*3 C/UL)-Abnormal High | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | NEUTROPHILS (ABSOLUTE) (X10*3 C/UL)-Abnormal Low | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | BLOOD UREA NITROGEN (MG/DL)-Abnormal High | 3 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | POTASSIUM, SERUM (MEQ/L)-Abnormal Low | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | CHLORIDE, SERUM (MEQ/L)-Abnormal High | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | CALCIUM, TOTAL (MG/DL)-Abnormal Low | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | PHOSPHORUS, INORGANIC (MG/DL)-Abnormal Low | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | MAGNESIUM, SERUM (MEQ/L)-Abnormal Low | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal Low | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal High | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | PROTEIN, TOTAL (G/DL) -Abnormal Low | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | ALBUMIN (G/DL)-Abnormal Low | 2 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | PROTEIN, URINE (N/A)-Abnormal High | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, URINE (N/A)-Abnormal High | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | BLOOD, URINE (N/A)-Abnormal High | 1 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | RBC, URINE (HPF)-Abnormal High | 0 Participants |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | WBC, URINE (HPF)-Abnormal High | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | CREATINE KINASE (U/L)-Abnormal High | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal Low | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | ERYTHROCYTES (X10*6 C/UL)-Abnormal Low | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | LEUKOCYTES (X10*3 C/UL)-Abnormal High | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | PROTEIN, URINE (N/A)-Abnormal High | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | WBC, URINE (HPF)-Abnormal High | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | PROTEIN, TOTAL (G/DL) -Abnormal Low | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | HEMOGLOBIN (G/DL)-Abnormal Low | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, URINE (N/A)-Abnormal High | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | BLOOD, URINE (N/A)-Abnormal High | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | POTASSIUM, SERUM (MEQ/L)-Abnormal Low | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | NEUTROPHILS (ABSOLUTE) (X10*3 C/UL)-Abnormal Low | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | CHLORIDE, SERUM (MEQ/L)-Abnormal High | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | RBC, URINE (HPF)-Abnormal High | 2 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | ALBUMIN (G/DL)-Abnormal Low | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | HEMATOCRIT (%)-Abnormal Low | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | CALCIUM, TOTAL (MG/DL)-Abnormal Low | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | MAGNESIUM, SERUM (MEQ/L)-Abnormal Low | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | BLOOD UREA NITROGEN (MG/DL)-Abnormal High | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | LEUKOCYTES (X10*3 C/UL)-Abnormal Low | 1 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | PHOSPHORUS, INORGANIC (MG/DL)-Abnormal Low | 0 Participants |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal High | 1 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | PHOSPHORUS, INORGANIC (MG/DL)-Abnormal Low | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | MAGNESIUM, SERUM (MEQ/L)-Abnormal Low | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | BLOOD, URINE (N/A)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal Low | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | LEUKOCYTES (X10*3 C/UL)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | HEMOGLOBIN (G/DL)-Abnormal Low | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | PROTEIN, TOTAL (G/DL) -Abnormal Low | 1 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | LEUKOCYTES (X10*3 C/UL)-Abnormal Low | 1 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | ALBUMIN (G/DL)-Abnormal Low | 1 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | ERYTHROCYTES (X10*6 C/UL)-Abnormal Low | 1 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | CREATINE KINASE (U/L)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | RBC, URINE (HPF)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | PROTEIN, URINE (N/A)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | HEMATOCRIT (%)-Abnormal Low | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | POTASSIUM, SERUM (MEQ/L)-Abnormal Low | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | GLUCOSE, URINE (N/A)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | CHLORIDE, SERUM (MEQ/L)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | BLOOD UREA NITROGEN (MG/DL)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | CALCIUM, TOTAL (MG/DL)-Abnormal Low | 1 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | WBC, URINE (HPF)-Abnormal High | 0 Participants |
| Arm 4: Heathy Participants | Number of Participants Experiencing Clinical Lab Abnormalities | NEUTROPHILS (ABSOLUTE) (X10*3 C/UL)-Abnormal Low | 1 Participants |